Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer

NCT07465497 | Enrolling By Invitation DMC

• 1 other identifier: PRO-106-25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research protocol is to evaluate whether supplementation with: synbiotics (probiotics with agave inulin), synbiotics with vitamid D or prebiotics (agave inulin) can reduce cognitive decline in patients with breast cancer undergoing neoadjuvant chemotherapy. It will also assess the safety of these supplements. The main questions it aims to answer are: Does supplementation with synbiotics and prebiotics decrease cognitive decline in participants? What adverse effects do participants experience while taking these supplements? Are there significant changes in inflammation markers (calprotectin and C-reactive protein) before and after treatment? Participants will: Receive either synbiotics, prebiotics or none daily for 4 months. Undergo cognitive assessments using the CERAD neuropsychological battery at the beginning and end of the study. Provide blood and stool samples for analysis of inflammation markers. Report any adverse effects experienced during the supplementation period.

Conditions

Chemobrain; Breast Cancer; Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

• Neuropsychological battery

  Cognitive assessments using the CERAD neuropsychological battery.

  Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.

Secondary Outcomes (2)

• C-reactive Protein

  Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.

• Calprotectin

  Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.

Study Arms (4)

Synbiotic

ACTIVE COMPARATOR

The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Lactobacillus acidophilus (LA3) Lactobacillus delbrueckii subsp. bulgaricus (SP 96) Lactobacillus casei (BGP 93) Lactobacillus plantarum (BG 112) Lactobacillus sporogenes, Lactobacillus rhamnosus and Agave Inulin)

Dietary Supplement: Synbiotics Blend

Synbiotic with vitamin D3

ACTIVE COMPARATOR

The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Inulin, Lactobacillus rhamnosus, Lactobacillus plantarum, D3 Vitamin/Colecalciferol, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus lactis)

Dietary Supplement: Synbiotics + Vitamin D

Prebiotic

ACTIVE COMPARATOR

The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Agave inulin.

Dietary Supplement: Prebiotic

No synbiotic/prebiotic

NO INTERVENTION

Participants in this arm won't have an intervention.

Interventions

Prebiotic DIETARY_SUPPLEMENT

Agave Inulin

Prebiotic

Synbiotics Blend DIETARY_SUPPLEMENT

Lactobacillus and inulin

Synbiotic

Synbiotics + Vitamin D DIETARY_SUPPLEMENT

Lactobacillus, inulin and colecalciferol.

Synbiotic with vitamin D3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Participants must be between 18 and 75 years old.
• Diagnosis: Must have a confirmed diagnosis of breast cancer at stages IB to IIIC.
• Treatment Status: Participants should be scheduled to receive neoadjuvant chemotherapy as part of their treatment plan.
• Cognitive Function: Must demonstrate baseline cognitive function as assessed by the CERAD neuropsychological battery, indicating no severe cognitive impairment.
• Informed Consent: Participants must provide written informed consent to participate in the study and comply with all study procedures.
• Health Status: Should not have any significant comorbidities that could interfere with the study outcomes, such as severe psychiatric disorders or neurological conditions.
• No Previous Probiotic Use: Must not have used probiotics or prebiotics in the month prior to the study

You may not qualify if:

• Severe Cognitive Impairment: Participants with significant cognitive impairment or dementia as assessed by the CERAD neuropsychological battery will be excluded.
• Severe Comorbidities: Participants with serious comorbid conditions, such as uncontrolled diabetes, severe cardiovascular diseases, or active infections, will be excluded.
• Psychiatric Disorders: Individuals with a history of severe psychiatric disorders that could affect cognitive function or compliance with the study protocol will be excluded.
• Neurological Conditions: Participants with neurological disorders such as multiple sclerosis, Parkinson's disease, or other conditions that affect cognitive function will be excluded.
• Pregnant or Lactating Women: Pregnant or breastfeeding women will not be eligible to participate in the study.
• Allergies: Individuals with known allergies to any of the components of the synbiotics or prebiotics used in the study will be excluded.
• Non-compliance Risk: Participants who are deemed at risk of non-compliance with study procedures or follow-up will be excluded.

Sponsors & Collaborators

• Instituto Jalisciense de Cancerologia: lead
• Instituto Oncológico Nacional: collaborator
• Instituto Tecnológico y de Estudios Superiores de Occidente: collaborator
• University of Guadalajara: collaborator

Study Sites (1)

Instituto Oncológico Nacional

Zapopan, Jalisco, 44660, Mexico

Location

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment; Breast Neoplasms

Interventions

Synbiotics; Vitamin D; Prebiotics

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: randomized, double blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Researcher

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

ME (1)